Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis

The goal of this clinical trial is to measure changes in the nasal airway after treatment with the VivAer® procedure in adults aged 22 to 85 with nasal airway obstruction caused by nasal valve dysfunction. The main questions it aims to answer are:

Are there measurable changes in the nasal airway and airflow after treatment with the VivAer procedure?

Participants will:

Undergo the VivAer procedure, which uses radiofrequency energy to remodel tissue in the nasal valve area. Have endoscopic images of their nasal airway taken before treatment and at follow-up visits at 3 and 6 months after treatment, which will be analyzed using the VISIONAIR™ AI System. They will complete symptom and quality of life surveys at each visit, including the Nasal Obstruction Symptom Evaluation (NOSE) Scale, the STOP-BANG Sleep Score, and the Short-Form (SF-12) Health Survey.

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Key information

Conditions

Nasal Airway Obstruction Airway Obstruction Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

22 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 22 to 85 years old (inclusively).
Willing and able to provide consent.
Willing and able to comply with the patient-specific requirements and follow-up schedule outlined in the study protocol.
Has a NOSE Score of ≥ 55.
Has a documented diagnosis of NAO with NVC (static or dynamic) as the primary driver of NAO symptoms.
Has a documented positive Modified Cottle Maneuver (using curette or equivalent to perform maneuver and evaluate nasal valve function).

Exclusion criteria

Has had rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic surgery (FESS) within the preceding 3 months.
Has uncontrolled chronic rhinitis as a contributor to nasal obstruction symptoms.
Has a complex nasal anatomy (e.g., anatomical deformity) or a history of significant nasal trauma that is a potential contributor to nasal obstruction symptoms.
Has any intranasal conditions that preclude adequate visualization of the nasal valve area.
Has a medical condition(s) that may impair normal healing processes.
Any adjunctive surgical or other nasal procedure (e.g., concha bullosa resection, inferior turbinate out fracture, septoplasty, etc.) on the same day or planned within 6 months of the study procedure.
Has current or recent (within 30 days prior to screening) exposure to oral systemic corticosteroids or is expected to require oral corticosteroid therapy during the course of the study.
Has nasal polyps, or a history of nasal polyps requiring medical or surgical treatment within the past 12 months.

Treatment and study plan

Vivaer Stylus

Device

Bipolar radiofrequency energy delivered to the lateral nasal wall at the upper lateral cartilage using the VivAer® Stylus and Aerin Console at device default settings (temperature 60°C, power 4 watts, treatment time 18 seconds, cooling time 12 seconds) to remodel submucosal tissue, including cartilage, in the internal nasal valve area.

Primary outcomes

Change in nasal valve angle and cross-sectional area

Time frame: Baseline to 3- and 6-months post-procedure.

Quantitatively assess anatomic improvement of the internal nasal valve (INV) and nasal airway following VivAer treatment using VISIONAIR™ analysis.

Study contacts

Contact information is provided by the study sponsor or research team.

Neda Haque

CONTACT

[email protected]

(408) 784-9452

Tien Dang

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Aerin Medical

Industry

Registry information

Official study title

Quantitative Evaluation of Nasal Airway Remodeling Following Temperature-Controlled Radiofrequency Treatment for Nasal Airway Obstruction Using AI-Assisted Analysis (BREATHE AI)

Acronym: BREATHE AI

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: May 8, 2026
Registry last updated: May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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